Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer (C-PiACs)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Breast Cancer

Treatments: Biological: Immunomonitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04645849

38RC19.362

2019-A02900-57 (Other Identifier)

Details and patient eligibility

About

This study aim to determine kinetic of post treatment recovery/variation of a panel of innate and adaptative immune system cells and molecules.

The results should allow to determine the optimal post treatment immunomonitoring timing and panel to be used for future studies.

Full description

There is a complexe interaction between tumor cells ans host immunity. Immunity system (IS) is clearly involved in cancer developement control, and it is suggested that it could participate to the response to anti cancer treatment.

There is however no validated immunomonitoring strategy to allow a reliable patient's immune status along time, and particularly after treatment.There are scarce existing information on immunologic reconstitution profile recovery after treatment.

This study aim to perform immunomonitoring in young patients with cancer to describe kinetic of recovery/variation of a panel of innate and adaptative immune system cells and molecules, selected by their potential relevance according to literature.

The concerned population are young women (˂40 yo) with breast cancer.

There will be 2 patients cohorts A or "End of treatment" : patients recruited at the end of treatment (study cohort) B or "Diagnosis" : Patients recruited at diagnosis (reference values)

This study should contribute to give sufficient data to determine the pertinent timing and cells/molecules panel to evaluate immunity profiling after treatment.

These results could be used for further studies.

Enrollment: 26 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with Breast cancer at initial diagnosis OR at the end of treatment
• Chemotherapy planned or performed in the treatment plan
• Patient not opposed to participate to the present study
• Affiliated to a French social security scheme.

Exclusion criteria

• metastatic breast cancer
• pregnant or breastfeeding woman
• Treatment with monoclonal antibodies or immunotherapy
• Immunosuppressive therapy
• Thymus irradiation
• Chronic infection in progress
• Inborn or acquired disease (other than breast cancer) impacting the immune system (SAA, Lupus...)
• Subject under guardianship or deprived of liberty

Trial design

26 participants in 2 patient groups

Cohort A or "End of treatment"

Description:

16 patients recruited at the end of breast cancer treatment and followed during 9 months

Treatment:

Biological: Immunomonitoring

Cohort B or "Diagnosis"

Description:

Patients recruited at breast cancer before any treatment: one blood sample to provide comparative values.

Treatment:

Biological: Immunomonitoring